Reported Mar 29, 2017 · Terminated
ARTIS Q, Interventional Fluroscopic x-ray system
Siemens Medical Solutions USA, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Siemens Medical Solutions USA, Inc · 40 Liberty Blvd · Malvern, PA · 19355-1418
Is this the product you have?
- ARTIS Q, Interventional Fluroscopic x-ray system
- Lot codes and dates
- Model # 10848280, 10848281, 10848282, 10848283, 10848353, 10848354, 10848355 Serial #
112 of 112 codes
109033117012121061109080109074121006121013121040105007111005109016121062111002121082121011121039123008109066109067109068121053121054117001117023123003123011109084121014121051109011121004117021121018121036123013123014117029117006121012121049103013109015121019109057121010117034103008109038109040109034117020109029111003121015109064109009117018117030109058121016
- Model # 10848280, 10848281, 10848282, 10848283, 10848353, 10848354, 10848355 Serial #
- Amount recalled
- 264 distributed worldwide (112 in the U.S.)
This recall covers 6 products
The agency filed one notice per product. You are reading one of them; the other 5 are below.
Why it was recalled
In Artis systems with A100G generators, a component can be affected by aging which could result in the potential failure of a module in the high-voltage generator.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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